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Registration & Licensing of Food Business, India

All
Food Business Operators in the country will be registered or licensed in
accordance with the procedures laid down hereinafter;

2. Registration of Petty Food
Business

a.
Every petty Food Business Operator shall register themselves with the
Registering Authority by submitting an application for registration in Form A
under Schedule 2 of these Regulations along with a fee as provided in Schedule
3.

b.
The petty food manufacturer shall follow the basic hygiene and safety
requirements provided in Part I of Schedule 4 of these Regulations and provide
a self attested declaration of adherence to these requirements with the
application in the format provided in Annexure-1 under Schedule 2.

c.
The Registering Authority shall consider the application and may either grant
registration or reject it with reasons to be recorded in writing or issue
notice for inspection, within 7 days of receipt of an application for
registration.

d.
In the event of an inspection being ordered, the registration shall be granted
by the Registering Authority after being satisfied with the safety, hygiene and
sanitary conditions of the premises as contained in Part II of Schedule 4
within a period of 30 days.

If
registration is not granted, or denied, or inspection not ordered within 7 days
as provided in above sub regulation (3) or no decision is communicated within
30 days as provided in above sub regulation (4), the petty food manufacturer
may start its business, provided that it will be incumbent on the Food Business
Operator to comply with any improvement suggested by the Registering Authority
even later.

Provided
that registration shall not be refused without giving the applicant an
opportunity of being heard and for reasons to be recorded in writing.

(5)
The Registering Authority shall issue a registration certificate and a photo
identity card, which shall be displayed at a prominent place at all times
within the premises or vehicle or cart or any other place where the person
carries on sale/manufacture of food in case of Petty Food Business.

(6)
The Registering Authority or any officer or agency specifically authorized for
this purpose shall carry out food safety inspection of the registered
establishments at least once in a year.

Provided
that a producer of milk who is a registered member of a dairy Cooperative
Society registered under Cooperative Societies Act and supplies or sells the
entire milk to the Society shall be exempted from this provision for
registration.

2.1.2 License for food business

(1)
Subject to Regulation 2.1.1, no person shall commence any food business unless
he possesses a valid license.

Provided
that any person or Food Business Operator carrying on food business on the date
of notification of these Regulations, under a license, registration or
permission, as the case may be, under the Acts or Orders mentioned in the
Second Schedule of the Act shall get their existing license converted into the
license/registration under these regulations by making an application to the
Licensing/Registering Authority after complying with the safety requirements
mentioned in the Schedule 4 contained under different Parts dependent on nature
of business, within one year of notification of these Regulations. In case of
difficulty, the licensing authority with the approval of the Food Safety
Commissioner in the State will determine the advisability of applying any
specific condition keeping in view the need to ensure safety of food and public
interest. No license fee will have to be paid for the remaining period of the
validity of the earlier license or registration granted under any of the said
Acts or Orders. Non-compliance with this provision by a Food Business Operator
will attract penalty under section 55 of the Act.

Provided
further that any food business operator holding Registration/License under any
other Act/Order as specified under schedule 2 of the FSS Act, 2006 with no
specific validity or expiry date, and other wise entitled to obtain a license
under these regulations, shall have to apply and obtain a Registration/License
under these Regulations within one year from the date of notification by paying
the applicable fees.

(2)
Notwithstanding the provisions contained in Regulation 2.1.2(1) above or in any
of the registration or license certificates issued under existing Acts or
Orders mentioned in the second schedule of the Act, the Licensing Authority, if
it has reason to believe that the Food Business Operator has failed to comply
with all or any of the conditions of the existing registration or license or
the safety requirements given in Schedule 4, may give appropriate direction to
the Food Business Operator to comply with.

(3)
License for commencing or carrying on food business, which falls under Schedule
1, shall be granted by the Central Licensing Authority, provided that Food
Authority may through notification make such changes or modify the list given
in the Schedule I as considered necessary.

(4)
License for commencing or carrying on food business, which are not covered
under Schedule 1, shall be granted by the concerned State/UT’s Licensing
Authority.

(5)
The Food Business Operator shall ensure that all conditions of license as
provided in Annexure 2 of Form B in Schedule 2 and safety, sanitary and hygienic
requirements provided in the Schedule 4 contained under different Parts
depending on nature of business are complied with at all times .

Provided
that the Licensing Authority shall ensure periodical food safety audit and
inspection of the licensed establishments through its own or agencies
authorized for this purpose by the FSSAI.

Provided
further that no person shall manufacture, import, sell, stock, exhibit for
distribution or sale any article of food which has been subjected to the
treatment of irradiation, except under a license obtained from Department of
Atomic Energy under the Atomic Energy (Control of Irradiation of Food)
Regulations, 1996.

2.1.3 Application for license to the
Licensing Authority

An
application for the grant of a license shall be made in Form B of Schedule 2 to
the concerned Licensing Authority as specified in Regulation 2.1.2 (3) and
2.1.2 (4) and it will be accompanied by a self-attested declaration in the
format provided in the Annexure-1 and copies of documents mentioned in the
Annexure 2 of Schedule-2 along with the applicable fees prescribed in Schedule
3.

(1)
A license shall, subject to the provisions of these Regulations, be issued by
the concerned Licensing Authority within a period of 60 days from the date of
issue of an application ID number as provided in subsection (3) below.

(2)
If, upon scrutiny of the application within 15 days from the date of receipt of
the application, the concerned Licensing Authority requires any additional
information with respect to an application or if the application is incomplete,
the Licensing Authority shall inform the applicant in writing, to furnish such
additional information or complete the application, as the case may be, within
30 days from such notice. In case the applicant fails to furnish the required
information within the stipulated time of 30 days, the application for license
shall stand rejected.

(3)
On the receipt of a complete application including the additional information
if asked for, the Licensing Authority shall issue an Application ID number to
each applicant that will be referred to in all future correspondence between
the Licensing Authority and the applicant.

(4)
After the issue of Application ID number the Licensing Authority may direct the
Food Safety Officer or any other person or agency specially designated for such
functions to inspect the premises in the manner prescribed by the Food Safety
and Standard Authority of India in accordance with these Regulations. Such
Inspecting Officer or person may issue a notice to the applicant, if it deems
fit, guiding food business operator on necessary steps to be taken or changes
or alteration to be made in the premises in order to ensure general sanitary
and hygienic conditions as specified in Schedule 4. The applicant shall carry
out the required steps, changes or alterations and intimate the Licensing
Authority within 30 days or such period as may be allowed by the Licensing
Authority.

(5)
Within a period of 30 days from receipt of an inspection report excluding the
time taken by the applicant in complying with the advice, if any, given in the
inspection report and verification thereof, the concerned Licensing Authority
shall consider the application and may either grant license or reject the
application.

Provided
that before refusing license an applicant shall be given an opportunity of
being heard and the reasons for refusal shall be recorded in writing.

(6)
The Licensing Authority shall issue a License in Format C under Schedule 2 of
these Regulations, a true copy of which shall be displayed at a prominent place
at all times within the premises where the Food Business Operator carries on
the food business.

2.1.5. Procedure for License in
certain local areas

(1)
A single license may be issued by the Licensing Authority for one or more
articles of food and also for different establishments or premises in the same
local area including collection and chilling units run by milk cooperatives or
its members.

(2)
The Chief Executive Officer of the Food Safety and Standards Authority of India
in the capacity of Food Safety Commissioner may appoint a Designated Officer or
Food Safety Officer for Central Government organizations like Railways, Defense
etc., which have a large number of food establishments, to ensure food safety
in those establishments and to ensure that all other conditions laid down for
running food business under the Act and these Regulations are complied with.
Provided further that the Food Authority may carry out food safety audit of
these establishments once in a year through its own or accredited agencies.

2.1.6. Commencement of Business

An
applicant may commence his food business and the concerned licensing Authority
shall not deny the applicant to commence such business if, from the date of
making the completed application, a license is not issued within 60 days or the
applicant has not received any intimation of inadequacy under Regulation
2.1.4(2) or inspection report indicating defects from the concerned Licensing
Authority under Regulation 2.1.4(4)

2.1.7. Validity and Renewal of
Registration and License

(1)
A Registration or license granted under these Regulations shall be valid and
subsisting, unless otherwise specified, for a period of 1 to 5 years as chosen
by the Food Business Operator, from the date of issue of registration or
license subject to remittance of fee applicable for the period and compliance
with all conditions of license.

(2)
Any application for the renewal of a registration or license granted under
these Regulations shall be made in Form A or B of Schedule 2, as the case may
be, not later than 30 days prior to the expiry date indicated in the license.

(3)
The Registration or License shall continue to be in force till such time that
the orders are passed on the renewal application which in no case shall be
beyond 30 days from the date of expiry of registration or license.

(4)
Any renewal application filed beyond the period mentioned under Regulation
2.1.7 (2) above but before the expiry date, shall be accompanied by a late fee
of Rs 100 per day for each day of delay.

(5)
Any Registration or license for which renewal has not been applied for within
the period mentioned in Regulation 2.1.7 (2) or 2.1.7 (4) above shall expire
and the Food Business Operator shall stop all business activity at the
premises. The Food Business Operator will have to apply for fresh Registration
or license as provided in Regulation 2.1.1 and 2.1.3 as the case may be, if it
wants to restart the business.

(6)
Food Business Operator having valid certificate of an accredited food safety
auditor or from an agency accredited by Food Authority or any other
organisation notified by food Authority for this purpose will not be normally
required to be inspected before renewal of license.

Provided
that Designated Officer may order an inspection before renewal if considered
necessary for reasons to be recorded in writing.

2.1.8. Suspension or cancellation of
Registration Certificate or license

(1) The Registering or Licensing Authority
in accordance with the provisions of section 32 of the Act may, after giving
the concerned Food Business Operator a reasonable opportunity of being heard,
suspend any registration or license in respect of all or any of the activities
for which the registration/license has been granted under these Regulations
after recording a brief statement of the reasons for such suspension, if there
is reason to believe that the Food Business Operator has failed to comply with
the conditions within the period mentioned in any Improvement Notice served
under Section 32 of the Act. A copy of such statement shall be furnished to the
concerned Food Business Operator whose Registration or license has been
suspended.

(2)
The registering or Licensing Authority, as the case may be, may direct an
inspection of the Food Business Operator’s premise(s) within a reasonable
period which shall not be less than 14 days from the date of order of
suspension.

(3)
In the event that the Registering or Licensing Authority is of the opinion, on
a review of the inspection report, that the Food Business Operator has still
failed to rectify the defects or omissions or comply with the conditions of the
improvement notice causing the suspension, such authority may cancel the
license/registration of the Food Business Operator after giving him an
opportunity to show cause as provided under Section 32 (3) of the Act.

(4)
Notwithstanding anything contained in these Regulations, the Registering or
Licensing Authority may suspend or cancel any registration or license forthwith
in the interest of public health for reasons to be recorded in writing.

(5)
A suspension or cancellation of registration or license under these Regulations
shall not entitle the Food Business Operator for any compensation or refund of
fee(s) paid in respect of the registration certificate or license or renewal
thereof.

(6)
After a period of 3 months from the date of cancellation under Regulation 2.1.8
(3) above the Food Business Operator may make fresh application for
Registration or license to the concerned authority if all observations made in
the improvement notice have been complied with. .

2.1.9. Modifications, Expansion or
Changes in premise(s) after grant of license or registration

(1)
Food Business Operators shall ensure that the Registering or Licensing
Authority always has up-to-date information on their food business
establishments and shall inform the relevant Authority of any modifications or
additions or changes in product category, layout, expansion, closure, or any
other material information based on which the license was granted and such
information shall be conveyed before the changes occur.

Provided
that any change that alters the information contained in the license
certificate shall require an approval or endorsement in license prior to start
of business with such changes. The Food Business Operator shall submit the
original license to the Licensing Authority along with a fee equivalent to one
year license fee for effecting necessary changes. The licensing Authority may
approve and issue an amended license incorporating such changes in activities
within 30 days from the date of receipt of such information. While approving
the afore mentioned changes the concerned registering or Licensing Authority
shall take into account the feasibility of carrying on the business and the legal
and other relevant aspects of the desired modifications or additions or changes
in activities and, if required, may order an inspection of the premises before
granting the approval.

2.1.10 Mode of payment:

All
fees and charges payable under these regulations shall be paid vide pay order
or demand draft or any online mode of payment as may be prescribed in this
regard, by the concerned Food Safety Commissioner.

2.1.11Transfer of registration certificate or License in case of death

(1)
In the event of death of the holder of a Registration certificate or license,
such certificate or license shall subsist for the benefit of the legal
representative or any family member of the deceased or until the expiry of:—

(a) The period of 90 days from the date of
death of the holder of a Registration certificate or license; or (b) such
longer period as the Designated Officer may allow, for reasons to be recorded
in writing.

The
legal representative or family member of the deceased holder of the
registration certificate or license shall apply to the concerned Authority for
transfer of such certificate or license in his favour.

The
registering or Licensing Authority, as the case may be, may, after making such
enquiry as it may deem fit, either approve the transfer of the Registration
certificate or license if satisfied that the applicant is the legal
representative, or refuse the request. Provided that the registering or
licensing authority shall not refuse the request without giving the applicant
an opportunity of being heard and for reasons to be recorded in writing.

Upon
filing of application for transfer and pending the decision of the authority,
the registration or license shall continue to be in force.

(1)
Every licensee shall on or before 31st May of each year, submit a return
electronically or in physical form as may be prescribed by the concerned Food
Safety Commissioner, in ‘Form D-1’ provided in Schedule 2 of these Regulations to the
Licensing Authority in respect of each class of food products handled by him
during the previous financial year.

Provided
however that every licensee engaged in manufacturing of milk and/or milk
products shall file half yearly returns for the periods 1st April to 30th
September and 1st October to 31st March of every financial year in the form
D-2, as provided in Schedule-2 of these regulations. Such returns will be filed
within a month from the end of the period.

(2)
A separate return shall be filed for every license issued under the
Regulations, irrespective of whether the same Food Business Operator holds more
than one license.

(3)
Any delay in filing return beyond 31st May of each year shall attract a penalty
of Rs 100 per day of delay.

2.1.14Food Business Operator to be bound by directions or order

(1)
Every Food Business Operator to whom any direction or order is issued in
pursuance of any provisions of this regulation shall be bound to comply with
such directions or regulation and any failure on the part of the Food Business
Operator to comply with such direction or order shall be deemed to be
contravention of the provisions of these Regulations and will attract legal
action under the provisions of the Act.

(2)
Guarantee every manufacturer, distributor or dealer selling an article of food
to a vendor shall give either separately or in the bill, cash memo, or label a
warranty in Form E. (Refer Form A for form of Guarantee)

2.1.15Power of State/UT governments to constitute advisory committee

The
state/UT Governments, may, if required designate an existing advisory committee
at panchayat/district/ state level or where such a committee does not exist,
constitute an advisory committee to assist, aid or advise on any matter
concerning food safety.

2.1.16: Jurisdiction of Designated
officer

The
Commissioner of Food Safety shall, by an order, appoint the Designated officer,
who shall not be below the rank of a Sub- Divisional Officer, to be in-charge
of food safety administration for each district as defined under regulation
1.2.1 (2)

List of food business falling under
the purview of Central Licensing Authority

1)
Dairy units including milk chilling units equipped to handle or process more
than 50,000 litres of liquid milk/day or 2500 MT of milk solid per
annum.

2)
Vegetable oil processing units and units producing vegetable oil by the process
of solvent extraction and refineries including oil expeller unit having
installed capacity more than 2 MT per day.

3)
All food processing units other than mentioned under (I) to (IV) including
relabellers and repackers having installed capacity more than 2 MT/day except
grains, cereals and pulses milling units.

6)
All food business operators manufacturing any article of food containing
ingredients or substances or using technologies or processes or combination
thereof whose safety has not been established through these regulations or
which do not have a history of safe use or food containing ingredients which
are being introduced for the first time into the country.

7)
Food Business Operator operating in two or more states.

8)
Food catering services in establishments and units under Central government
Agencies like Railways, Air and airport, Seaport, Defence etc.